Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’

Stakeholder no.

Section No.

Comment and rationale

Proposed change / recommendation

development as well as part of the regulatory decision making,. i.e. from early on through out the entire process until approval covering the entire ICH members as well as those countries/regions taking the ICH recommendations into account. This is a very important global step further for both patients, sponsors and regulatory authorities to increase the quality, relevance, benefit/risk and information to the decision-makers. The draft, reflection paper covers in a structured manner a broad examples of opportunities for integrating patient perspectives during the entire medicines Research & development (R&D) and approval processes, although not exhaustive as indicated in line 71. The opportunitie are huge, although focus are agreed to the need for two new ICH guidelines covering what (COAs) and how (methods), respectively, are agreed to as global, standards/harmonized manners to identifying, collecting and analysing meaningful, prioritised patient perspectives. It is important that two key points are taken into account: 1. The standars should not be so complex and time consuming that it delay or even prevent the significant timewise and economic benefits of having patient perspectives as a natural and important part of medicines R&D and decision-making 2. The involved patients keep a true declaration of “no conflict of interest” in relation to the concerned

Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’ (EMA/CHMP/ICH/415588/2020) EMA/194133/2021

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